Huntington DiseasePhase 1NCT05238701
A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects
A Phase 1 study testing LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant in people with Huntington Disease and Tardive Dyskinesia, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease, Tardive Dyskinesia
- What is being tested?
- LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2022to 4 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject who voluntarily participate and sign the informed consent form;
- Healthy male/female volunteers aged 18 to 45 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 28.0 kg/m2, inclusive;
- Able to comply with the lifestyle restrictions.
Who cannot join
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
- Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
- Subject has a history of self-mutilation; or at risk of suicide;
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
- Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
Show all 18Show fewer
- Subject has used any of over-the-counter products within 14 days or prescription medications within 28 days prior to dosing;
- Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
- Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
- Subject has a history of substance abuse or a positive urine drug screen;
- Subject who has daily smoking of ≥ 5 cigarettes;
- Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
- Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
- Subject who has participated in other clinical trials within 3 months before administration;
- Subject has used blood products or being blood donor or blood loss;
- Pregnant, lactating women, or positive pregnancy test;
- Subject who refusal to contraception, or plan to donate sperm or ovums;
- Other conditions which would make participation in the study unsuitable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy Subjects
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.
- Conditions
- Huntington Disease, Tardive Dyskinesia
- Being tested
- LPM3770164 sustained release tablet, LPM3770164 sustained release tablet simulant
- Medical subject headings
- Huntington Disease, Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPM3770164 sustained release tabletDrug
Also called LY03015
LPM3770164 sustained release tablet will be administrated orally single-dose on day 1
LPM3770164 sustained release tablet simulantDrug
Also called LY03015 simulant
LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1
| Study group | Role | What they receive |
|---|---|---|
| LPM3770164 | Experimental | LPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg Receives: Drug: LPM3770164 sustained release tablet |
| Placebo | Placebo comparator | LPM3770164 sustained release tablet simulant will be administrated with single dose Receives: Drug: LPM3770164 sustained release tablet simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse effects
Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Measured: from baseline to day 28
Secondary outcomes (20)
Maximum observed concentration (Cmax)
Measured: from baseline to day 15
Time to maximum observed concentration (Tmax)
Measured: from baseline to day 15
Area under the concentration-time curve (AUC)
Measured: from baseline to day 15
Clearance (CL)
Measured: from baseline to day 15
Half-life (t1/2)
Measured: from baseline to day 15
Mean Residence Time (MRT)
Measured: from baseline to day 15
Haematology
Measured: baseline, day 3, day 8, day 15, day 28
Blood Chemistry
Measured: baseline, day 3, day 8, day 15, day 28
Urinalysis
Measured: baseline, day 15, day 28
Coagulation
Measured: baseline, day 15, day 28
Body Temperature
Measured: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Respiratory Rate
Measured: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Blood Pressure
Measured: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Pulse Rate
Measured: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Physical Examination
Measured: baseline, day 15, day 28
12 lead electrocardiogram corrected QT interval
Measured: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Simpson-Angus Rating Scale (SAS)
Measured: baseline, day 3, day 28
Barnes Akathisia Rating Scale (BARS)
Measured: baseline, day 3, day 28
Abnormal Involuntary Movement Scale (AIMS)
Measured: baseline, day 3, day 28
Stanford Sleepiness Scale (SSS)
Measured: baseline, day 3, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start25 Feb 2022
- Primary completion4 Nov 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hufang Li, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238701
- Sponsor's protocol ID
- LY03015/CT-CHN-101
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05238701
- Acronym / sponsor ID
- LY03015/CT-CHN-101
- Conditions
- Huntington Disease, Tardive Dyskinesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPM3770164 | Experimental | Drug: LPM3770164 sustained release tabletLPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg |
| Placebo | Placebo comparator | Drug: LPM3770164 sustained release tablet simulantLPM3770164 sustained release tablet simulant will be administrated with single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject who voluntarily participate and sign the informed consent form;
- Healthy male/female volunteers aged 18 to 45 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 28.0 kg/m2, inclusive;
- Able to comply with the lifestyle restrictions.
Key exclusion criteria (18 listed)
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
- Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
- Subject has a history of self-mutilation; or at risk of suicide;
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPM3770164 sustained release tabletAlso: LY03015LPM3770164 sustained release tablet will be administrated orally single-dose on day 1 | Drug | LPM3770164 |
| LPM3770164 sustained release tablet simulantAlso: LY03015 simulantLPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1 | Drug | Placebo |
Primary outcome
Treatment-emergent adverse effects
Time frame: from baseline to day 28
Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
20 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: from baseline to day 15
Time to maximum observed concentration (Tmax)
Time frame: from baseline to day 15
Area under the concentration-time curve (AUC)
Time frame: from baseline to day 15
Clearance (CL)
Time frame: from baseline to day 15
Half-life (t1/2)
Time frame: from baseline to day 15
Mean Residence Time (MRT)
Time frame: from baseline to day 15
Haematology
Time frame: baseline, day 3, day 8, day 15, day 28
Blood Chemistry
Time frame: baseline, day 3, day 8, day 15, day 28
Urinalysis
Time frame: baseline, day 15, day 28
Coagulation
Time frame: baseline, day 15, day 28
Body Temperature
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Respiratory Rate
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Blood Pressure
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Pulse Rate
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Physical Examination
Time frame: baseline, day 15, day 28
12 lead electrocardiogram corrected QT interval
Time frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Simpson-Angus Rating Scale (SAS)
Time frame: baseline, day 3, day 28
Barnes Akathisia Rating Scale (BARS)
Time frame: baseline, day 3, day 28
Abnormal Involuntary Movement Scale (AIMS)
Time frame: baseline, day 3, day 28
Stanford Sleepiness Scale (SSS)
Time frame: baseline, day 3, day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Huntington Disease
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingPhase 1
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
Huntington's Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hufang Li, Doctor principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant in people with Huntington Disease and Tardive Dyskinesia, run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse effects (time frame: from baseline to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.